Sr. Manager Software Compliance - Columbus, OH

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Senior Manager Software Compliance

Nourish the world and your career as part of the Nutrition team at Abbott.

Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® – to help get the nutrients they need to live their healthiest life.

WHAT YOU’LL DO

MAIN RESPONSIBILITIES

• Lead team responsible for software quality assurance validation efforts and system compliance to federal regulations (e.g. 21 CFR Part 11, cGMP, Data Integrity, etc) and provide strategic direction and guidance for organization, sites and providers to achieve superior quality software products while maintaining a proper balance between quality, compliance, cost, and timeliness.
• Provides the business with consistent guidance in the creation, interpretation, and implementation of software quality systems.  Assures consistent interpretation and implementation of regulatory requirements and software process improvement initiatives for the business.
• Communicate risk and compliance issues regarding computerized systems validation and vendor audits to Management. Foster communication and cooperation between software quality and development, information technology, operations technology, and the user community.
• Maintain Quality System (QS) processes, procedures, templates and job aids and create new QS documents as needed.  Provide change management.
• Provide validation training on validation policies and practices.
• Provide guidance on defining the validation & verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports.  Review, analyze and provide recommendations for verification and validation test data.
• Responsible for ongoing support of Validation Management System (VMS) software.
• Supports site audits and support and/or lead CAPA investigations and Global Impact Assessment Reports.
• Participates and advises in Validation Review Board meetings as needed.
• Develop and track validation related metrics. 

EDUCATION AND EXPERIENCE, YOU’LL BRING

MINIMUM REQUIRED QUALIFICATIONS

• B.S. degree in engineering, science, or technical related field or equivalent education and experience.
• 5+ years of experience in design/process verification and validation in a regulated

environment such as Medical Devices, Pharmaceutical Products or Food Manufacturing.

• Experience creating verification and validation strategy, plans, protocols and reports.
• Knowledgeable in System Life Cycle.
• Demonstrated capability to solve technical problems and a high degree of accuracy and analytical thinking.
• Strong verbal and written communication skills.
• A high degree of interpersonal relations skills.
• Must be able to deal effectively with problems and internal customers.
• Must be able to work under pressure and stress common to office environments.
• Must have solid working knowledge of Microsoft Office Suite.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority
• Production areas that are clean, well-lit and temperature-controlled
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation and incentives
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: